Healthy VolunteersPhase 1NCT01012310
Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects
A Phase 1 study of Healthy Volunteers, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of this study is to determine the safety and toleration of single and multiple doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083 and its metabolites, following single and multiple dose administration in healthy male and/or female subjects; and to determine whether… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2009to Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects btween the ages of 18-55 years
- Body Mass Index (BMI) of 15.5 to 30.5 and a total body weight greater than 50kg (110 lbs).
Who cannot join
- Evidence or history of clinically signifcant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 21 drinks/week within 6 months of screening
- Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
- Pregnant or nursing females; females of childbearing potentioal who are unwilling or unable to use an acceptable method on contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, 3rd Party Open, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects
The purpose of this study is to determine the safety and toleration of single and multiple doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083 and its metabolites, following single and multiple dose administration in healthy male and/or female subjects; and to determine whether PF-04531083 raises levels of enzymes involved in metabolism of other drugs following multiple dosing).
- Conditions
- Healthy Volunteers
- Being tested
- PF-04531083 or Placebo
- Keywords
- pharmacokinetics safety tolerability multiple dosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04531083 or PlaceboDrug
Subjects will receive multiple oral doses of less than or equal to 100mg PF-04531083 or placebo for 14 days.
PF-04531083 or PlaceboDrug
Subjects will receive multiple oral doses of less than or equal to 300mg PF-04531083 or placebo for 14 days.
PF-04531083 or PlaceboDrug
Subjects will receive multiple oral doses of less than or equal to 500mg PF-04531083 or placebo for 14 days.
PF-04531083 or PlaceboDrug
A fourth cohort may be used to investigate alternative dosing regimens, formulations or food effects.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: PF-04531083 or Placebo |
| Cohort 2 | Experimental | Not described Receives: Drug: PF-04531083 or Placebo |
| Cohort 3 | Experimental | Not described Receives: Drug: PF-04531083 or Placebo |
| Cohort 4 | Experimental | Not described Receives: Drug: PF-04531083 or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index
Measured: days 1-15
Safety of subjects following multiple dosing of PF-04531083 (adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood and urine safety tests)
Measured: days 1-15
Secondary outcomes (1)
pharmacokinetics of alternative formulations
Measured: days 1-15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012310
- Sponsor's protocol ID
- B1351002
- Status last verified
- Apr 2010
- First submitted
- 11 Nov 2009
- Last updated
- 16 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, 3rd Party Open, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01012310
- Acronym / sponsor ID
- B1351002
- Conditions
- Healthy Volunteers
- Keywords
- pharmacokinetics safety tolerability multiple dosing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and toleration of single and multiple doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083 and its metabolites, following single and multiple dose administration in healthy male and/or female subjects; and to determine whether PF-04531083 raises levels of enzymes involved in metabolism of other drugs following multiple dosing).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PF-04531083 or Placebo |
| Cohort 2 | Experimental | Drug: PF-04531083 or Placebo |
| Cohort 3 | Experimental | Drug: PF-04531083 or Placebo |
| Cohort 4 | Experimental | Drug: PF-04531083 or Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and/or female subjects btween the ages of 18-55 years
- Body Mass Index (BMI) of 15.5 to 30.5 and a total body weight greater than 50kg (110 lbs).
Key exclusion criteria (5 listed)
- Evidence or history of clinically signifcant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 21 drinks/week within 6 months of screening
- Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
- Pregnant or nursing females; females of childbearing potentioal who are unwilling or unable to use an acceptable method on contraception.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-04531083 or PlaceboSubjects will receive multiple oral doses of less than or equal to 100mg PF-04531083 or placebo for 14 days. | Drug | Cohort 1 |
| PF-04531083 or PlaceboSubjects will receive multiple oral doses of less than or equal to 300mg PF-04531083 or placebo for 14 days. | Drug | Cohort 2 |
| PF-04531083 or PlaceboSubjects will receive multiple oral doses of less than or equal to 500mg PF-04531083 or placebo for 14 days. | Drug | Cohort 3 |
| PF-04531083 or PlaceboA fourth cohort may be used to investigate alternative dosing regimens, formulations or food effects. | Drug | Cohort 4 |
Primary outcome
Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index
Time frame: days 1-15
Safety of subjects following multiple dosing of PF-04531083 (adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood and urine safety tests)
Time frame: days 1-15
1 secondary outcome
pharmacokinetics of alternative formulations
Time frame: days 1-15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Healthy Volunteers, run by Pfizer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index (time frame: days 1-15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2010.